FSMA Inspections Shaken Up by COVID-19, What's Next?

Written by: Paul Davis, Ph.D.   |   June 4, 2021

Federal agencies, Feed safety, Policy priority series

This blog is part of our policy priority series.

Being somewhat of a data and details geek, one of the more enjoyable parts of my responsibilities at the American Feed Industry Association is monitoring and evaluating Food Safety Modernization Act inspections in the animal food industry. We are fortunate to have the opportunity to periodically meet with the Food and Drug Administration staff to discuss the agency’s inspections goals and objectives.

In addition to the number of inspections, we also monitor the types of facilities inspected, geographic diversity and frequency of Form 483s being issued after inspections (this happens when investigators may observe conditions that require action). Through contracts and cooperative agreements with state departments of agriculture and its own personnel, the FDA has done very well in achieving its inspectional goals over the last several years – of course that was prior to the COVID-19 pandemic, which hampered nearly all aspects of daily life.

As many parts of our country shut down with shelter-in-place orders, travel restrictions, prohibitive visitor policies and local mandates, as expected, the FDA was unable to meet all of its inspectional goals for fiscal 2020, which began Oct. 1, 2019, and was affected by the pandemic for almost six of its 12 months. While the agency largely reached its inspection goals for the current good manufacturing practice (cGMP) portion of FSMA, it only completed a fraction of the planned number of hazard analysis/preventive controls inspections. So far, all of the FDA’s fiscal 2021 goals have been affected by the pandemic and its restrictions. Undoubtedly, this has hampered conducting inspections, particularly for FDA personnel.

At the height of the pandemic, the FDA suspended all routine inspections and investigated only “for cause” or “mission critical” to protect public health. Additionally, the FDA began requesting records for remote review and viewing some documents using online platforms until inspectors and investigators could get back into the field. Earlier this year, the agency held a one-month pilot project for remote records review, which was limited to records associated with the Veterinary Feed Directive. By all accounts – it went well! We expect to hear observations and assessment of the pilot from the FDA soon, as well as plans going forward.

Cancelled inspections and changes in methodology leave many of us to wonder: what is next in the inspectional landscape?

It seems Congress has also taken notice of the recent reduction in inspections and has been asking the FDA questions, as the activities of the FDA’s Office of Regulatory Affairs (ORA) receives about 70% of the money appropriated to the FDA.

The FDA has responded to some questions and addressed its plans in its recently released, “Resiliency Roadmap for FDA Inspectional Oversight,” document. In the document, the FDA recognizes that based on the number of remaining inspections and continued challenges related to the pandemic, meeting its goals for surveillance inspections this fiscal year is unlikely. For the remainder of the inspectional year, the FDA will prioritize animal food inspections using a tiered system to designate “tier 1,” as mission critical; “tier 2,” as higher priority; and “tier 3,” as routine surveillance, including non-high-risk and sampling assignments. Further, the report includes models that account for various scenarios that may play out during the remainder of fiscal 2021 and estimates of how many inspections may be completed under the different scenarios.

With the interests of our members in mind, we will continue to monitor and evaluate the FDA’s inspectional activities and provide input and feedback to the agency as appropriate. Or, in other words, I will continue to “geek out” on the inspectional data and details.